Regulatory Specialist

Engineering jobs >> Engineering




Austin Vita have an exciting opportunity for a Regulatory Specialist to join a leading Medical Device manufacturer on a 6 month contract to support the team with an MDR compliance across Class I, IIa and Class IIb devices.

As a Regulatory Specialist you will be instrumental in ensuring compliance to the European Medical Device Regulation (MDR). This will involve assessing, preparing, monitoring and communicating the status of regulatory needs within the team.

With a GAP analysis already in place, your day to day role will see you support technical file remediation activities, design reviews, labeling and IFU's. Any experience relating to product registration including FDA, 510(k) and CE marking is a strong advantage. You may also look into the initial review of complaints to determine and record reportability whilst also supplying information relating to Product Registrations in the desired markets.

The role is looking for someone to start ASAP, therefore if it could be of interest please apply and I will be in touch.

Austin Fraser is acting as an Employment Business in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants
  • 1
  • Negotiable
  • None
  • None
  • CV-108492
  • Contract
  • 3

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